Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds

Launched by AVITA MEDICAL · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special treatment called Cohealyx Collagen Dermal Matrix for patients with full thickness wounds, such as burns or surgical wounds. The main goal is to find out how long it takes for this treatment to help heal the wounds after surgery. If you or a family member has a serious wound that needs a skin graft and will be hospitalized soon after an injury, you might be eligible to participate in this study.

To take part, patients should be having a planned surgery soon after their injury and must be willing to follow all study procedures and attend scheduled visits. It's important that participants do not have any current infections or serious medical conditions that could affect their safety during the trial. Throughout the study, participants will receive care while doctors monitor their healing process to gather valuable information about the effectiveness of the Cohealyx treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all the following criteria to be eligible for participation:
• • 1. The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
• • 2. The patient is hospitalized within 3 days of injury.
• • 3. The surgical excision occurs within 5 days post-injury.
• • 4. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
• • 5. The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (26 weeks post-autografting).
• 6. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
• • 1. Understand the full nature and purpose of the study, including possible risks and adverse events,
• • 2. Understand instructions, and
• • 3. Provide voluntary written informed consent
• Exclusion Criteria:
• Subjects who meet any of the following criteria are not eligible for participation:
• • 1. Clinical signs of wound infection at study area.
• • 2. The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trial evaluations or objectives.
• • 3. The patient is unable to understand English or Spanish.
• • 4. The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
• • 5. Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).